PRIMEAUTY BOTTLE (PUMP)- alcohol liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

Huizhou Duomei Daily Necessities Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antimicrobial - For hand washing to decrease bacteria on the skin - Recommended for repeated use - Stop use and ask a doctor if - irritation and redness develop and persist for more than 72 hours - Swallowed, get medical help or contact a poison control center right away.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PRIMEAUTY BOTTLE (PUMP)- ALCOHOL LIQUID
HUIZHOU DUOMEI DAILY NECESSITIES CO., LTD.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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PRIMEAUTY (PET BOTTLE W/ PUMP)
ACTIVE INGREDIENT(S)
Ethyl Alcohol 75% Purpose: Antimicrobial
PURPOS E
Antimicrobial
US ES
For hand washing to decrease bacteria on the skin
Recommended for repeated use
WARNINGS
DO NOT USE in the eyes. In case of contact, rinse eyes thoroughly with
water.
FOR EXTERNAL USE ONLY.
FLAMMABLE, KEEP AWAY FROM HEAT AND FLAME
STOP USE AND ASK A DOCTOR IF
irritation and redness develop and persist for more than 72 hours
Swallowed, get medical help or contact a poison control center right
away.
KEEP OUT OF REACH OF CHILDREN. Children must be supervised in use of
this product.
DIRECTIONS
Put enough product on hands to cover all surfaces. Rub hands together
until dry.
Children under 6 years of age should be supervised when using this
product.
OTHER INFORMATION
Store below 110F (43C)
May discolor certain fabrics or surfaces
INACTIVE INGREDIENTS
Water, Glycerin, Carbomer, Triethanolamine, Tocopheryl Acetate, Aloe
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
PRIMEAUTY BOTTLE (PUMP)
alcohol liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7518 6 -0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)
ALCOHOL
75 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
GLYCERIN (UNII: PDC6 A3C0 OX)
WATER (UNII: 0 59 QF0 KO0 R)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)
ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:7518 6 -0 0 1-
0 1
240 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n
Pro duc